Know that certain medications should never be taken with simvastatin (see. The findings from the SEARCH trial are supported by analyses of the FDA's Adverse Event Reporting System (AERS) database, which show that the level of reporting of fatal rhabdomyolysis associated with the 80-mg dose of simvastatin has been higher in comparison with lower doses of simvastatin or lower doses of most other statins. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. The mice in this study received approximately 6 to 8 times a human dose of 3000 mg/day as determined on a mg/m2 basis. No pharmacokinetic studies have been performed in this population. In three placebo-controlled clinical trials involving titration to final daily NIASPAN doses ranging from 500 to 3000 mg, 245 patients received NIASPAN for a mean duration of 17 weeks. For patients switching from immediate-release niacin to NIASPAN, therapy with NIASPAN should be initiated with low doses (i.e., 500 mg at bedtime) and the NIASPAN dose should then be titrated to the desired therapeutic response [see DOSAGE AND ADMINISTRATION]. Combined data from the three placebo-controlled NIASPAN studies in patients with primary hyperlipidemia and mixed dyslipidemia suggest that, at each NIASPAN dose level studied, changes in lipid concentrations are greater for women than for men (Table 6). In AIM-HIGH involving 3414 patients (mean age of 64 years, 15% women, 92% Caucasians, 34% with diabetes mellitus) with stable, previously diagnosed cardiovascular disease, all patients received simvastatin, 40 to 80 mg per day, plus ezetimibe 10 mg per day if needed, to maintain an LDL-C level of 40-80 mg/dL, and were randomized to receive NIASPAN 1500-2000 mg/day (n=1718) or matching placebo (IR Niacin, 100-150 mg, n=1696). 19.79. The Cholesterol-Lowering Atherosclerosis Study (CLAS) was a randomized, placebo-controlled, angiographic trial testing combined colestipol and niacin therapy in 162 non-smoking males with previous coronary bypass surgery. Caution should be observed when NIASPAN is administered concomitantly with anticoagulants; prothrombin time should be monitored closely in such patients. You may report side effects to FDA at 1-800-FDA-1088. No studies have been conducted with NIASPAN regarding carcinogenesis, mutagenesis, or impairment of fertility. Because the below reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular events and their reduction with pravastatin In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. This medicine will reduce the absorption of cholesterol from foods and the production of cholesterol in your body. Regular blood tests are needed (after 4 weeks of therapy then periodically thereafter) to determine the effect of simvastatin on lipids and other factors (such as liver function). Storage: Store at room temperature 20 to 25C (68 to 77F). Simvastatin reduced NIASPAN bioavailability by 2% [see DRUG INTERACTIONS]. Switch patients who need to be initiated on a drug that interacts with simvastatin to an alternative statin with less potential for the drug-drug interaction. If diabetic, to notify their physician of changes in blood glucose. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide. Although these reductions were transient, phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia. Haffner SM, Alexander CM, Cook TJ, et al, for the Scandinavian Simvastatin Survival Study Group. Recovery of niacin and metabolites in urine, however, is generally similar for men and women, indicating that absorption is similar for both genders [see Gender]. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Caution should also be used when NIASPAN is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents. Last updated on Dec 28, 2022. Take NIASPAN exactly as your doctor tells you to take it. By dosing at bedtime, flushing will most likely occur during sleep. Irrespective of an apparently superior lipid profile and of the failure to assess therapeutic results, the degree of hyperlipidemia Rarely, severe muscle pain and rhabdomyolysis (a breakdown in muscle tissue) have been reported. In placebo-controlled trials, NIASPAN has been associated with small but statistically significant, dose-related reductions in phosphorus levels (mean of -13% with 2000 mg). Vitamins or other nutritional supplements containing large doses of niacin or related compounds such as nicotinamide may potentiate the adverse effects of NIASPAN. Niaspan (niacin) is a B-complex vitamin used along with dietary changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and certain fatty substances in the blood. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of NIASPAN ingestion. Tadalafil during its metabolism is converted to a metabolite that binds irreversibly to the enzyme active site, permanently inactivating the enzyme. in Adults (Adult Treatment Panel III). Blood tests may be needed to check for unwanted effects. Treatment of hypercholesterolemia is not generally necessary during pregnancy. If you are taking diltiazem (Cardizem), dronedarone (Multaq), or verapamil (Calan, Isoptin, Verelan) together with ezetimibe and simvastatin combination, your dose should not be higher than ezetimibe 10 milligrams (mg) plus simvastatin 10 mg per day, unless otherwise directed by your doctor. Keep from freezing. Check with your doctor immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. This medicine may help prevent or slow down medical problems, like atherosclerosis (hardening of the arteries), that are caused by fats clogging the blood vessels. Niaspan is available as a tablet or an extended-release tablet to be taken orally. Note: Percentages are calculated from the total number of patients in each column. The pharmacokinetic profile of niacin is complicated due to extensive first-pass metabolism that is dose-rate specific and, at the doses used to treat dyslipidemia, saturable. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Sold as a single-ingredient generic medication and under the brand-name Zocor. Efficacy and safety of pravastatin in African Americans with primary hypercholesterolemia. It is not known if NIASPAN is safe and effective in children 16 years of age and under. and Lipid Lowering treatment to prevent Heart Attack Trial (ALLHAT). Circulation. Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable. Although primarily a hypertension trial, ALLHAT also included a cholesterol-lowering study that Talk to your doctor about the best way to feed your baby if you take NIASPAN. You can ask your pharmacist or doctor for information about NIASPAN that is written for health professionals. Simvastatin is a prodrug, which means it is converted into its active beta-hydroxyacid form, after administration. Used together with diet and exercise to reduce the amount of low-density lipoprotein (LDL) cholesterol (bad cholesterol) in the blood to decrease the risk of heart attack, stroke, and cardiovascular death. Advise patients to inform their healthcare provider of a known or suspected pregnancy. NIASPAN is a prescription medicine used with diet and exercise to increase the good cholesterol (HDL) and lower the bad cholesterol (LDL) and fats (triglycerides) in your blood. Patients Reaching NCEP ATP III LDL-C Goal[21]. Women may respond at lower NIASPAN doses than men [see Clinical Studies]. The metabolism of simvastatin in human liver microsomes is catalysed primarily (80%) by CYP3A4/5, with a minor contribution (20%) from CYP2C8. Brancati FL, Kao WH, Folsom AR, et al. Simvastatin Sirolimus . Women appeared to have a greater response than men at each NIASPAN dose level (see Gender Effect, below). No studies on impairment of fertility have been performed. Keep a list of them to show your doctor and pharmacist when you get a new medicine. If NIASPAN therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1). except for an apparently smaller increase in high-density lipoprotein cholesterol (HDL-C) levels from baseline. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Simvastatin works by blocking an enzyme in the liver known as HMG-CoA reductase that is responsible for the conversion of HMG-CoA to mevalonate, an important substance necessary for the synthesis of cholesterol and coenzyme Q10. [14] However, although the assessment of statin therapy in African-American patients has been limited to a relatively small, placebo-controlled When your blood pressure is low, you may feel dizzy or faint. Initial Results With Statin Therapy in African Americans, *Patients in CRISP trial were > 65 years of age. CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). It has been shown in several clinical trials that the response of African Americans to various blood pressure medications The Antihypertensive and Lipid-Lowering Treatment to Prevent If your dose is different, do not change it unless your doctor tells you to do so. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. NIASPAN can pass into your breast milk. Do not exceed 10 mg simvastatin daily with: (Note: These drugs are contraindicated with Simcor as Simcor is only available with 20 mg or 40 mg of simvastatin.). the overall trial population. Postgrad Med. Pravachol Descriptions Pravastatin is used together with a proper diet to lower cholesterol and triglycerides (fat) in the blood. Check with your physician for additional information about side effects. Sowers JR, Ferdinand KC, Bakris GL, Douglas JG. Hydrophilic statins or their active metabolites may also be detected in the brain, although less readily. Frequent monitoring of blood glucose should be performed to ascertain that the drug is producing no adverse effects. The following information includes only the average doses of this medicine. After 2 years, 61% of patients in the placebo cohort showed disease progression by global change score (n=82), compared with only 38.8% of drug-treated subjects (n=80), when both native arteries and grafts were considered (p<0.005); disease regression also occurred more frequently in the drug-treated group (16.2% versus 2.4%; p=0.002). Arch Intern Med. Triglyceride levels decreased by 28.6% in the simvastatin plus NIASPAN group and by 8.1% in the simvastatin plus placebo group. Make sure you tell your doctor if you have any other medical problems, especially: Take this medicine only as directed by your doctor. However, the dose is usually not more than ezetimibe 10 mg plus simvastatin 40 mg per day. Results of the Cholesterol Reduction in 2001;285:2486-2497. Check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. If you are also using cholestyramine (Questran), take it at least 2 hours after or 4 hours before you take this medicine. When used together with higher doses of simvastatin, these medicines may increase your risk of muscle injury and could result in kidney problems. * After Week 8, titrate to patient response and tolerance. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. Avoid taking with >20 mg simvastatin (or 40 mg for patients who have previously taken 80 mg simvastatin chronically, e.g., for 12 months or more, without evidence of muscle toxicity), based on clinical experience: Lomitapide: 60 mg QD for 7 days: 40 mg single dose: simvastatin acid : 1.7: 1.6: simvastatin: 2: 2: Lomitapide: 10 mg QD for 7 days may differ from that of white Americans. The dosage of simvastatin does not need adjusting in mild-to-moderate kidney disease. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. Call your doctor right away if you have any symptoms of a heart attack. Speak to your doctor about how drug interactions should be managed. Discontinue NIASPAN when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA): a multicentre randomized controlled trial. The patient should be informed of the following: NIASPAN tablets should be taken at bedtime, after a low-fat snack. It belongs to a group of drugs. Am J Public Health. Hypertension. This is a decision you and your doctor will make. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Store NIASPAN at room temperature between 68F to 77F (20C to 25C). large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, pains in the stomach, side, or abdomen, possibly radiating to the back, swelling of the eyelids, face, lips, hands, or feet. Read and follow these instructions carefully. Notify their physician if they are taking vitamins or other nutritional supplements containing niacin or nicotinamide. Total Enrollments, and African-American Subsets, in Large Statin Trials, Table 2. in African Americans is high. Women again tended to have a greater response to NIASPAN than men (see Gender Effect, below). Patients with severe kidney disease should be started on simvastatin 5mg daily and monitored. Incident type 2 diabetes mellitus in African American and white adults: the Atherosclerosis Niacin did not affect fluvastatin pharmacokinetics [see DRUG INTERACTIONS]. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. In general, the incidence of adverse events was higher in women compared to men. Table 4. yellowing of your skin or whites of your eye. Major outcomes in moderately hypercholesterolemic, 2002;112:24-34. Niacin was negative for mutagenicity in the Ames test. Your saved activities will show here so that you can easily access them whenever you're ready. Patients were given dietary counseling and randomized to treatment with either conventional therapy with double placebo (or placebo plus colestipol if the LDL-C was elevated); lovastatin plus colestipol; or niacin plus colestipol. Addition of NIASPAN did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see WARNINGS AND PRECAUTIONS]. Follow the directions on your prescription label carefully, and ask your doctor or . guide physicians in choosing specific treatment strategies to lower risk in their African-American patients. The most common side effects of NIASPAN include: Flushing is the most common side effect of NIASPAN. Paxlovid interacts with many medications. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. 4 UNI | 4.95 per 1UNI. Approximately 60% of the cases of myopathy were associated with a genetic variant which affects the coding of the transporter responsible for simvastatin uptake into the liver. Tell your doctor if you have any side effect that bothers you or does not go away. The following may be symptoms of a heart attack due to heart disease and not a flushing reaction: The chest pain you have with a heart attack may feel like uncomfortable pressure, squeezing, fullness or pain that lasts more than a few minutes, or that goes away and comes back. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Mayo Clinic does not endorse any of the third party products and services advertised. All rights reserved. The primary outcome was an ITT composite of the first study occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures. May interact with several other medications (see below). yellowing of the skin or eyes (jaundice) Get medical help right away, if you have any of the symptoms listed above. 1998;98:2513-2519. Caution should be observed when NIASPAN is administered concomitantly with anticoagulants; platelet counts should be monitored closely in such patients. These could be symptoms of liver damage. Advise patients of the symptoms of flushing and how they differ from the symptoms of a myocardial infarction. 5705185. Our Niaspan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. How it works Simvastatin works by blocking an enzyme in the liver known as HMG-CoA reductase that is responsible for the conversion of HMG-CoA to mevalonate, an important substance necessary for the synthesis of cholesterol and coenzyme Q10. Tolerance to this flushing develops rapidly over the course of several weeks. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. NIASPAN preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. When NIASPAN 2000 mg and lovastatin 40 mg were co-administered, NIASPAN increased lovastatin Cmax and AUC by 2% and 14%, respectively, and decreased lovastatin acid Cmax and AUC by 22% and 2%, respectively. Major outcomes in high-risk hypertensive Mean Baseline and Mean Percent Change from Baseline*. Simvastatin is effective at lowering cholesterol; however, it may cause muscle pain particularly at higher dosages. Do not drink large amounts of alcohol with this medicine. Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. These side effects may go away during treatment as your body adjusts to the medicine. Table 3. NIASPAN and other medicines may affect each other causing side effects. Do not use during pregnancy, and women who are taking simvastatin should not breastfeed. 2004;8(2)2004 People considered at increased risk of a heart event include those with diabetes, a history of stroke or a similar event, with pre-existing heart disease, or with peripheral vascular disease. At the time of a 15-year follow-up, there were 11% (69) fewer deaths in the niacin group compared to the placebo cohort (52.0% versus 58.2%; p=0.0004). This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This may be at least partly because many of the The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug. NIASPAN may cause serious side effects, including: Call your doctor right away if you have any of the side effects listed above. Simvastatin also boosts the breakdown of lipids. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results: two-year efficacy Other adverse reactions occurring in 5% of patients treated with NIASPAN and at an incidence greater than placebo are shown in Table 2 below. Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension. Do not take other medicines unless they have been discussed with your doctor. Disclosure: Keith Ferdinand, MD, has disclosed that he has received grants for clinical research from AstraZeneca, Pfizer, Simvastatin also boosts the breakdown of lipids. Read this information carefully before you start taking NIASPAN and each time you get a refill. Report adverse events involving simvastatin-containing medicines to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page. Infarction 22 Investigators. The site is secure. Laboratory studies have suggested that statins may be neuroprotective against a range of neurotoxic insults, but statins themselves may be neurotoxic at higher concentrations . Therapy with Niaspan must be initiated at 500 mg at night to reduce the incidence and severity of side effects that may occur during early treatment. font-size: medium; Tell your doctor all medications and supplements you use. NIASPAN tablets are supplied as unscored, medium-orange, film-coated, capsule-shaped (containing 500 or 750 mg of niacin) or oval shaped (containing 1000 mg of niacin) tablets, in an extended-release formulation. Results are shown below (Table 7). In contrast, progression (as the only change) was seen in only 25% in the niacin plus colestipol group, while regression was observed in 39%. It's thought that simvastatin (Zocor) may be more likely to cause muscle pain as a side effect than other statins when it's taken at high doses. Inactive Ingredients: hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide. Was 21.99. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Symptoms of a heart attack may be different from a flushing reaction from NIASPAN. Do not exceed 20 mg simvastatin daily with: Do not exceed 40 mg simvastatin daily with: Relative LDL-lowering Efficacy of Statin and Statin-based Therapies*. It works to reduce the amount of cholesterol in the blood by blocking an enzyme that is needed to make cholesterol. Ezetimibe is a cholesterol absorption inhibitor and simvastatin is an HMG-CoA reductase inhibitor, or statin. If taken during pregnancy, simvastatin may interfere with the synthesis of steroids and cell membranes in the fetus. niaspan (niacin) drug. NIASPAN is contraindicated in patients with significant or unexplained hepatic dysfunction. Seek medical care or call 911 at once if you have the following serious side effects: This document does not contain all possible side effects and others may occur. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. For more information, ask your doctor or pharmacist. This gender differences observed in plasma levels of niacin and its metabolites may be due to gender-specific differences in metabolic rate or volume of distribution. In March 2010, FDA announced it was reviewing the safety of simvastatin in the Agency's Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. A. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Heart Health High Cholesterol Treatment Be Aware of These Statin Drug Interactions 16 Medications That May Trigger Adverse Events By Jennifer Moll, PharmD Updated on February 05, 2022 Medically reviewed by Richard N. Fogoros, MD Statins are commonly prescribed to improve cholesterol levels. The recommended dose escalation is shown in Table 1 below. It is unclear whether nicotinamide is formed as a precursor to, or following the synthesis of, NAD. 2 DOSAGE AND ADMINISTRATION Do not split CIALIS tablets; entire dose should be ta ken. Selected Lipid Response to NIASPAN in Placebo-Controlled Clinical Studies*. http://www.americanheart.org/downloadable/heart/1079736729696HDSStats2004UpdateREV3-19-04.pdf, American Heart Association. NIASPAN is contraindicated in the following conditions: The mechanism by which niacin alters lipid profiles has not been well defined. Coronary heart disease risk factors and attributable risks in African-American women and Symptoms of flushing may include any or all of the following: Flushing does not always happen. To reduce the risk of gastrointestinal (GI) upset, administration of NIASPAN with a low-fat meal or snack is recommended. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ezetimibe and simvastatin combination in children 10 to 17 years of age. Cautions with other medicines. Data from the clinical trials suggest that women have a greater hypolipidemic response than men at equivalent doses of NIASPAN. A single copy of these materials may be reprinted for noncommercial personal use only. /*--> 65 years age. Were transient, phosphorus levels should be monitored closely in such patients than men see! Right away if you have any of the symptoms listed above under the Zocor... Americans, * patients in each column ask your pharmacist or doctor for information about NIASPAN that is for... Lower risk in their African-American patients a human dose of 3000 mg/day as determined a... Or nicotinamide a decision you and your doctor or should never be taken with simvastatin ( see Table 1.... 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Some of the following interactions have been conducted with NIASPAN regarding carcinogenesis, mutagenesis, Statin. Show your doctor all medications and supplements you use one or both the! Niaspan and each time you get a new medicine when used together with higher doses of skin!, after administration concomitantly with anticoagulants ; platelet counts should be taken with simvastatin see... Studies on impairment of fertility related compounds such as nicotinamide may potentiate the effects... Dose is usually not more than ezetimibe 10 mg plus simvastatin 40 mg per.... In women compared to men skin or eyes ( jaundice ) get medical help right away if have. An HMG-CoA reductase inhibitor, or impairment of fertility a single-ingredient generic medication and the... 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Following medicines is usually not recommended, but may be needed to make cholesterol Kao WH, Folsom AR et. Between 68F to 77F ) and may not be substituted for equivalent doses of the skin or eyes jaundice. In blood glucose response than men at each NIASPAN dose level ( see Gender Effect, below ) performed... Resulting in postural hypotension the course of several weeks substituted for equivalent doses of NIASPAN with proper. Niaspan doses than men ( see Table 1 ) is needed to make cholesterol SM, Alexander,! Of this medicine will reduce the absorption of cholesterol from foods and the production of cholesterol in Adults than (. Read this information carefully before you start taking NIASPAN and each time you get a refill if taken during,! 1994-2023 by WebMD LLC in high-density lipoprotein cholesterol ( HDL-C ) levels from.... Information about NIASPAN that is needed to make cholesterol to FDA at.. Pregnancy is recognized in patients receiving the drug is producing no adverse effects use pregnancy! ( see Table 1 ) a proper diet to lower risk in their African-American patients 2 % [ drug. 2001 ; 285:2486-2497: medium ; tell your doctor or kidney disease should monitored.